The present invention relates to the introduction of an artificial lens to an eye. More specifically, the present invention relates to an apparatus and method for implanting a deformable intraocular lens into an eye.
The use of deformable intraocular lenses in the treatment of cataracts and other refractive problems has become commonplace. There are many devices and methods currently in use for the delivery of a deformable intraocular lens into the eye. Complications continue to arise out of the use of these devices and methods, specifically, damage to the ocular tissues and/or damage to the implanted deformable intraocular lens. There is a need for an apparatus and method for delivering a deformable intraocular lens to the eye which does not damage the ocular tissue or the implanted lens.
It is a first object of the present invention to provide an apparatus and method for introducing a deformable intraocular lens to the eye.
It is a second object of the present invention to provide an improved apparatus and method for introducing a deformable intraocular lens to the eye.
It is a third object of the present invention to provide an apparatus which deforms a deformable intraocular lens for introduction through a small ocular incision to the eye.
It is a fourth object of the present invention to provide an apparatus which moves a deformed intraocular lens into the eye.
It is a fifth object of the present invention to provide an apparatus which allows a deformed intraocular lens to release stored energy associated with the lens deformation process in a controlled manner.
It is a sixth object of the present invention to provide an apparatus which provides at least one tool for manipulating a lens within the eye.
It is a seventh object of the present invention to provide an apparatus which may be pre-loaded with a deformable intraocular lens.
It is an eighth object of the present invention to provide an apparatus which may be pre-loaded with a deformable intraocular lens in a non-deformed condition.
It is a ninth object of the present invention to reduce the potential for introduction of user error into the process for the delivery of a deformable intraocular lens to the eye.
It is a tenth object of the present invention to further automate the process for delivering a deformable intraocular lens to the eye.
It is an eleventh object of the present invention to provide an apparatus which allows a surgeon to view a deformed intraocular lens for determining whether the deformation of the lens is correct for delivery of the lens to the eye.
It is a twelfth object of the present invention to provide an apparatus which allows a surgeon to deform a deformable intraocular lens in preparation for delivery of the lens to the eye without the use of forceps.
It is a thirteenth object of the present invention to provide a deformable intraocular lens injecting apparatus including a lens injecting body including a lens receiver configured to be operated between an open configuration and a closed configuration, a nozzle portion provided with a tip portion configured to be inserted through a small incision into an eye, the nozzle portion configured for connection to the lens receiver of the lens injecting body, the nozzle portion and the lens receiver defining a lens delivery passageway, and a plunger slidably disposed relative to the lens delivery passageway and configured to engage a deformable intraocular lens within the lens delivery passageway of the lens receiver and to move the deformable intraocular lens out of the lens delivery passageway into the eye.
It is a fourteenth object of the present invention to provide a deformable lens injecting apparatus which stores a lens in a slightly vaulted configuration.
It is a fifteenth object of the present invention to provide a deformable intraocular lens injecting apparatus which deforms a lens in preparation for injection of the lens into the eye by greatly decreasing a radius of curvature introduced to the lens during loading of the lens into the apparatus.
It is a sixteenth object of the present invention to provide a deformable intraocular lens injecting apparatus having a lens receiver which stores the lens in a substantially non-deformed state and which deforms the lens in preparation for injection of the lens to the eye.
It is a seventeenth object of the present invention to provide a deformable lens injecting apparatus having a separate lens receiver.
It is an eighteenth object of the present invention to provide a deformable intraocular lens injecting apparatus having a deformable intraocular lens pre-loaded in a component of the apparatus in a hydrating environment.
It is a twentieth object of the present invention to provide a deformable intraocular lens injecting apparatus having a lens receiver provided with a pre-loaded lens and stored in a hydrating environment and further configured for connection to the apparatus within the hydrating environment.
The present invention provides an apparatus and method for inserting a deformable intraocular lens through a small incision into an eye. In a preferred embodiment the apparatus includes a lens injecting body including a lens receiver configured to be operated between an open configuration and a closed configuration, a nozzle portion provided with a tip portion configured to be inserted through a small incision into an eye, the nozzle portion configured for connection to the lens receiver of the lens injecting body, the nozzle portion and the lens receiver defining a lens delivery passageway; and, a plunger slidably disposed relative to the lens delivery passageway and configured to engage a deformable intraocular lens within the lens delivery passageway of the lens receiver, and to move the deformable intraocular lens out of the lens delivery passageway into the eye.
The present invention provides an apparatus which stores, deforms, and delivers a deformable intraocular lens to the eye.
In a preferred embodiment, the apparatus of the present invention is provided to surgical personnel as a package of separate components, each of which is further discussed below, which are assembled by surgical personnel for use.
A lens injecting body and plunger assembly define a component of the apparatus. A lens receiver which connects to the lens injecting body is provided separately from the lens injecting body and plunger assembly. The lens receiver is preferably provided with a pre-loaded deformable intraocular lens. A nozzle is also provided separately from the lens injecting body. Prior to use of the apparatus, the lens receiver is connected to the lens injecting body and plunger assembly and then the nozzle portion is connected to the lens injecting body and plunger assembly.
Through the use of separate components, the apparatus of the present invention provides a lens injecting body and plunger assembly to which a case specific lens receiver and/or case specific nozzle portion may be connected. In other words, surgical personnel need only become proficient in the use of a single lens injecting apparatus to treat a wide variety of patients according to the present invention.
The lens injecting body of the present invention is configured to provide a base or frame to which the other components of the apparatus are connected and also to provide a defined surface which is specifically configured to be easily hand held and manipulated by surgical personnel. Preferably, a lens injecting body is defined by an elongated, rigid, hollow body having a proximal portion including a finger rest for syringe type use of the apparatus and a distal end having first and second sets of tabs specifically configured to engage holes in a lens receiver and nozzle portion, respectively, according to the present invention.
A plunger according to the present invention is preferably provided with the lens injecting body. The plunger is moved relative to the lens injecting body to propagate a lens through a lens delivery passageway defined by the apparatus into the eye. The plunger is preferably further configured to allow surgical personnel to manipulate a lens within the eye.
Another major component of a preferred embodiment of an apparatus according to the present invention is the lens receiver. The lens receiver preferably provides a preloaded deformable intraocular lens, stores the pre-loaded lens in a substantially nondeformed configuration, deforms the lens according to a process for preparing the lens for injection, stores the lens temporarily in a substantially deformed configuration just prior to injection of the lens into an eye, and defines a portion of a lens delivery passageway through and out of which the lens is moved by the plunger of the apparatus into the eye.
A preferred embodiment of a lens receiver includes an elongated base portion and a pair of extending portions which hinge on either longitudinal side of the base portion for operating of the lens receiver between an open configuration and a closed configuration. In an open configuration, interior surfaces of the base portion and extending portions of the lens receiver define a platform which is configured to provide a substantial loading platform for accepting a deformable intraocular lens in a non-deformed configuration. Pre-loading of the lens, typically an optic portion surrounded by haptic portions, includes orienting the lens on the platform of the open lens receiver such that the optic portion is received in a recessed or tray portion of the base portion. Pre-loading also involves engaging each haptic portion of the lens within edge gripping portions of the extending portions. The lens is thereby fixated and predisposed to deformation necessary for delivery of the lens through a small ocular incision.
The lens receiver is further preferably provided with a removable shield portion which is configured to engage the pre-loaded lens receiver in an open configuration. The shield portion protects the lens in the lens receiver during storage and connection of the lens receiver to the lens injecting body. The shield portion also prevents the plunger tip from moving into the lens receiver when the lens receiver is connected to the lens injecting body.
A pre-loaded lens receiver according to the present invention is preferably stored in a sealed storage container of hydrating solution for preserving the lens during storage and delivery of the apparatus to surgical personnel. The hydrating solution may also be provided with a biocompatible lubricant for facilitating delivery of the lens to the eye from the apparatus. Prior to use, a seal is removed from the top of the container which preferably defines a port for receiving the distal end of the lens injecting body. The distal end of the lens injecting body is further configured to engage the proximal end of the lens receiver and to connect thereto by a snap fit connection. The connection occurs conveniently within the storage container. Once connected together, the lens injecting body and lens receiver are removed from the container. The shield portion is then removed from the lens receiver allowing the stored lens to be visually inspected and treated with biocompatible lubricant by surgical personnel.
The platform of the lens receiver is preferably provided with longitudinal ridges which facilitate dispersion of lubricant around the lens and minimize contact between the lens and lens receiver. Deformation of the lens is accomplished by the simple operation of the lens receiver from an open to a closed configuration. Specifically, each extending portion of the lens receiver is grasped simultaneously, preferably, by the thumb and forefinger, and hinged relative to the base portion. During operation of the lens receiver to a closed configuration, a slight radius of curvature introduced to the lens during pre-loading is greatly decreased thereby causing the haptic portions of the lens to curl inwardly and ultimately to slightly overlap within the lens receiver in a xe2x80x9crolledxe2x80x9d configuration. Each outer longitudinal edge of the lens receiver may be provided with cooperating locking structure. When the extending portions come together, these edges may interlock to complete the operation of the lens receiver from an open configuration to a closed configuration.
The apparatus of the present invention further includes a nozzle portion which provides a lens delivery passageway through which the deformed intraocular lens is delivered from the lens delivery passageway of the lens receiver to the intraocular implant site. The nozzle portion also serves to secure the lens receiver in a closed configuration and may also be used to manipulate the lens within the eye after ejection therefrom.
The preferred nozzle portion includes a base portion having a proximal end configured to connect to a distal portion of the lens injecting body. The nozzle portion also includes an extending portion and a tip portion which are configured to be introduced to the interior of the eye through a small ocular incision. Preferably, the extending portion is substantially transparent to allow surgical personnel to visually inspect a lens being pushed therethrough.
The nozzle tip portion is provided with a pair of slots which define first and second tip portions. First and second tip portions yield outwardly slightly under the force of a deformable intraocular lens being advanced therethrough and thus function to release elastic energy stored in the deformed lens prior to the complete release of the lens from the lens delivery passageway. First and second tip portions are also shaped differently and may be used to influence the speed and angle at which the lens exits from the lens delivery passageway as well as to manipulate the injected lens within the intraocular implant site.
To use an assembled apparatus according to the present invention, a retaining clip on the plunger is removed to allow the plunger to move relative to the lens injecting body. The plunger, and specifically the plunger tip is then advanced into engagement with the deformed intraocular lens within the lens receiver. Further advancement of the plunger moves the lens into the nozzle portion of the apparatus. The nozzle tip portion and extending portion are then inserted into the eye and the plunger is advanced further to move the lens out of the nozzle tip portion into the eye. Once within the eye, the plunger tip and nozzle tip portion may be used to further manipulate the lens into proper implanted position.